Compliance Engineer

Summary

ResMed is a global leader in health technology focused on improving patient outcomes through digital experiences. The Compliance Engineer will work closely with engineering teams to ensure regulatory compliance and manage audits, driving the technical compliance capabilities of the organization.

Responsibilities

• Act as SME for all the audits for ResMed's digital products
• Represent ResMed Engineering in audits, including but not limited to HDS, MDSAP, SOC2, and MDR
• Identify and evaluate technical design alternatives to achieve desired functionality in partnership with cross-functional team members and Systems Architecture Leaders
• Educate the engineering teams on the design review needs and facilitate the design review process among those teams
• Enhance or modify existing design review processes
• Help resolve technical issues
• Drive the bug-triage process and help determine issues that impact patient safety
• Participate in the product roadmaps and influence the release of features based on safety risk analysis
• Act as a bridge between Product Engineering and ResMed Quality/Regulatory teams and bring knowledge on the latest safety-related standards
• Ensure the company's technical compliance with applicable laws and regulations
• Collaborate with engineers and designers to deliver compliant products and services
• Responsible for researching and identifying applicable regulatory and industry compliance standards and codes
• Ensure product achieves performance, functionality and reliability as specified in the marketing and systems specification documents
• Act as SME for formal releases to ensure meeting all the needed compliance and regulatory-related deployment documentation
• Prepare compliance reports by collecting, analyzing, and summarizing measurement data and trends related to post-launch market data

Skills

• BS/MS in any engineering discipline. Computer science preferred. No hands-on coding experience is needed
• Working knowledge of regulations including but not limited to MDSAP, ISO13485:2016, IEC62304, SOC2 controls
• 3 years of experience delivering medical products and navigating through audits like MDR, SOC2, MDSAP, HDS, or any other regulatory framework is a plus
• Proficiency in report writing, analysis, and compliance procedures
• Thorough understanding of regulatory frameworks
• Solid technical knowledge and understanding of Software Product Life Cycle (SDLC)

Qualifications

Must Haves

• BS/MS in any engineering discipline. Computer science preferred. No hands-on coding experience is needed
• Working knowledge of regulations including but not limited to MDSAP, ISO13485:2016, IEC62304, SOC2 controls
• 3 years of experience delivering medical products and navigating through audits like MDR, SOC2, MDSAP, HDS, or any other regulatory framework is a plus
• Proficiency in report writing, analysis, and compliance procedures
• Thorough understanding of regulatory frameworks
• Solid technical knowledge and understanding of Software Product Life Cycle (SDLC)

Benefits

• Employees scheduled to work 30 or more hours per week are eligible for benefits.
• Comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance
• Sleep care management
• Health Savings Account (HSA)
• Flexible Spending Account (FSA)
• Commuter benefits
• 401(k)
• Employee Stock Purchase Plan (ESPP)
• Employee Assistance Program (EAP)
• Tuition assistance
• Employees receive fifteen days Paid Time Off (PTO) in their first year of employment
• Receive 11 paid holidays plus 3 floating days
• Are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members
• Flexible work arrangements
• A supportive environment that focuses on people development and best practices, with support both in and out of the work environment